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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Measuring the macro- and microvascular responses to LPS and exenatide

This research is focused on understanding how your body's blood vessels respond to certain substances, specifically in men. We are looking at both larger blood vessels and the smallest ones, called microvessels. The study is investigating a medicine called exenatide, which is usually given to people with diabetes. We want to see how this medicine affects blood flow when the body is also reacting to a substance called LPS. This is an early-stage study, meaning it's one of the first times this is being looked at in humans. The aim is to gather important information about how these processes work, which could help in treating conditions affecting the heart and how the body uses energy, known as metabolic diseases.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Centre for Human Drug Research
Enrolment target
30
Start
28 Jan 2025

What is this study about?

This study is about understanding how your blood vessels, both big and small, react to certain things. Imagine your body's plumbing system – we're looking at how the main pipes (macrovascular) and the very tiny pipes (microvascular) behave. Specifically, we're interested in a medicine called exenatide, which is commonly used to help people with diabetes manage their blood sugar. We want to see how this medicine might affect these blood vessels.

We're also looking at reactions to a substance called LPS. Don't worry, this isn't about giving you a serious illness. Researchers often use tiny, safe amounts of LPS in studies to gently remind the body's immune system to respond, which helps them understand how the body reacts to stress or other changes. By doing this, we can observe how exenatide might change or improve these responses in your blood vessels.

This is a very early stage of research, sometimes called a Phase I study. This means we're focused on gathering basic but important information about how this medicine works in the human body. The hope is that by understanding these responses better, we can eventually find better ways to help people who have heart and blood vessel problems, or conditions that affect how their body uses energy, like diabetes.

Key takeaways

  • The study explores how blood vessels react to medicines.
  • It focuses on a diabetes medicine called exenatide.
  • Only men aged 18 and over can take part.
  • It's an early-stage study to gather fundamental information.
  • Participation involves clinic visits and close monitoring.
  • Your contribution helps future understanding of heart and metabolic conditions.

Who may be eligible?

This study is looking for volunteers who are men aged 18 or older. There isn't an upper age limit, meaning older men can also take part.

To be considered for this study, you will need to meet certain health requirements. This ensures the study is safe for you and that the results are clear. The research team will carefully check your medical history to make sure you're a good fit.

Since this study focuses on specific body responses, it's particularly important that you don't have certain ongoing health conditions or take medicines that might affect the results.

Quick self-check
  • Are you a man?
  • Are you 18 years old or older?
  • Do you generally feel well and are you in good health?
  • Are you able to attend several study appointments?
  • Are you comfortable with blood tests and medical checks?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would first have a screening visit where doctors would check your health to make sure the study is suitable for you. If you qualify, you would then come for a few study visits, which might involve staying at the research clinic for a day or even overnight. During these visits, the research team would give you the study medicine (exenatide) and the LPS substance.

They would also take several measurements, which could include blood samples, checking your blood pressure, and using special equipment to look at how your blood vessels are working. You would be closely monitored throughout the study visits. The total time you would be involved in the study could vary, but it would involve a commitment to attend all scheduled appointments and follow the study instructions.

Potential risks and benefits

Taking part in a study like this could help researchers learn valuable information that might lead to better treatments for heart and metabolic conditions in the future, which is a benefit to society. For you personally, there might not be a direct health benefit from taking part. Potential risks are generally low in early-stage studies, but you might experience mild side effects from the study medicine or the LPS, like feeling a bit unwell, or discomfort from blood draws. You will be closely monitored, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Netherlands

Common questions

What is 'macro- and microvascular responses'?

It means how your large blood vessels (like arteries) and your very tiny blood vessels (like capillaries) react to things in your body. We're looking at how they change and respond.

What is exenatide?

Exenatide is a medicine commonly used to help people with type 2 diabetes manage their blood sugar levels.

What is LPS?

LPS is a substance that researchers sometimes use in very small, safe amounts to gently trigger a response from your body's immune system, helping them understand how your body reacts to certain changes.

Is this a new medicine?

Exenatide is already an approved medicine, but this study is looking at new ways it might affect your blood vessels, which is new information.

Will this study help me directly?

It's unlikely to have a direct health benefit for you, but the information learned will help doctors understand diseases better and could lead to new treatments in the future.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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